GSK (NYSE:GSK) 주식

In the pharmaceutical industry, GSK ranks as one of the largest firms by total sales. The company wields its might across several therapeutic classes, including respiratory, antiviral, and vaccines, and has been growing its presence in oncology and immunology, as well. GSK uses joint ventures to gain additional scale in certain markets like HIV.

GlaxoSmithKline

Toronto,,Ontario,,Canada,-,February,14,,2021,:,Gsk,Glaxosmithkline

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켄 그리핀의 헤지펀드 시타델(Citadel)이 GSK PLC(NYSE:GSK)에 3억 5,000만 파운드(3억 9,000만 달러)의 공매도 베팅을 걸었다. 이는 영국 제약 대기업 GSK에 대한 10년래 가장 큰 베팅이라고 파이낸셜타임스가 보도했다.

켄 그리핀의 헤지펀드 시타델, 제약사 GSK에 대규모 공매도 베팅

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네바다의 한 낙농업자가 1월에 루이지애나 남자의 사망과 관련된 조류 독감 D1.1 변종에 양성 반응을 보였다고 CNN이 보도했다. 미국 질병통제예방센터(CDC)는 월요일에 초기 양성 반응을 확인하기 위해 작업 중이다.

네바다 남성에서 발견된 치명적인 조류 독감 변종: 주목해야 할 4가지 주식

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미국 질병통제예방센터(CDC)가 세계보건기구(WHO)와의 협력을 중단한 것으로 알려지면서 전 세계 보건 우려가 월요일 높아지는 가운데, 캘리포니아에서 희귀한 H5N9 조류 독감 변종이 발견되어 백신 회의론자 로버트 F. 케네디 주니어에 대한 상원 인준 청문회가 예정된 것과 동시에 이루어졌다.

CDC-WHO 협력 중단 및 조류 독감으로 모더나, 화이자 상승; RFK Jr. 후보 인준 청문회 예정

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Trump Administration Health Agency Firings Include Staff Overseeing Bird Flu Response

GSK's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) short percent of float has fallen 5.49% since its last report. The company recently reported that it has 17.47 million shares sold short, which is 0.86% of all regular shares that are available for trading. Based on its trading volume, it would take traders 3.16 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>GSK Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1743017414_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for GSK has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing GSK's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, GSK's peer group average for short interest as a percentage of float is 4.22%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

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Looking Into GSK's Recent Short Interest

<a href="https://www.wsj.com/health/pharma/pfizer-covid-vaccine-2020-election-probe-2f3ec247" title="https://www.wsj.com/health/pharma/pfizer-covid-vaccine-2020-election-probe-2f3ec247">https://www.wsj.com/health/pharma/pfizer-covid-vaccine-2020-election-probe-2f3ec247</a>

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'U.S. Prosecutors Probe Tip About Timing Of Pfizer Vaccine; Claim Came To The U.S. Attorney's Office In Manhattan Via Pfizer Rival GSK' - WSJ

The US Food and Drug Administration (FDA) approved GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Blujepa&nbsp;(gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">tract infections (uUTIs)</a>.
In a press release on Tuesday, the company said the U.S. commercial <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44484272/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections-uut" rel="noreferrer noopener">launch is planned in 2H 2025</a>.
UTIs are the most common infection in women, impacting up to 16 million women in the US annually.
The approval is based on results from the pivotal phase 3 EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults and pediatric patients with a confirmed uUTI.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44121869/gsks-once-daily-inhalers-for-smokers-lung-has-potential-benefits-independent-organization-report" rel="noreferrer noopener">GSK&#8217;s Once-Daily Inhalers For Smoker&#8217;s Lung Has Potential Benefits: Independent Organization Report</a>
In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success, which occurred in 50.6% (162/320) of participants, compared to 47.0% (135/287) for nitrofurantoin.
In EAGLE-3,&nbsp;Blujepa&nbsp;demonstrated statistically significant superiority versus nitrofurantoin.
Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin.
The development of&nbsp;Blujepa&nbsp;has been partially funded by federal funds from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, the Biomedical Advanced Research and Development Authority, and federal funds awarded by the Defense Threat Reduction Agency.
Price Action: GSK stock is down 1.63% at $37.95&nbsp;at the last check Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/news/earnings/25/03/44493356/jinkosolar-cautious-on-2025-capacity-expansion-after-q4-loss-and-market-headwinds-details" target="_blank" rel="noreferrer noopener">JinkoSolar Cautious On 2025 Capacity Expansion After Q4 Loss And Market Headwinds: Details</a></li>
</ul>
Photo: Shutterstock

FDA Approves GSK's Oral Antibiotic For Urinary Tract Infections For Females Aged 12 Years And Older

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that APRETUDE (cabotegravir tablets and extended release injectable suspension) is now covered under the federal Non-Insured Health Benefits (NIHB) Program for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative.1
The Non-Insured Health Benefits (NIHB) Program provides eligible First Nations and Inuit people with coverage for a range of health benefits that are not otherwise covered through private, provincial, or territorial health insurance plans or social programs.2 In Canada approximately 10 per cent of all people living with HIV are Indigenous3, despite making up just five per cent of the country's population.4 Economic, social and systemic barriers, along with the lasting effects of racism and colonialism, all contribute to the disproportionate burden of HIV experienced by Indigenous people.5
The decision to reimburse APRETUDE through the NIHB Program will have a meaningful impact on HIV prevention efforts for eligible First Nations and Inuit people who are at-risk of HIV and could benefit from PrEP.

ViiV Healthcare Announces Reimbursement For APRETUDE For HIV-1 Pre-Exposure Prophylaxis Under The Non-Insured Health Benefits Program

<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf" title="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf">https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218230s000lbl.pdf</a>

GSK Gets FDA Approval Of Blujepa For Treatment Of Uncomplicated Urinary Tract Infections In Female Adults And Adolescents; This Is The First In A New Class Of Oral Antibiotic Treatment For uUTIs In Over 20 Years

The European Medicines Agency Has Accepted For Review Its Application To Expand The Use Of GSK's Nucala (Mepolizumab) As An Add-on Maintenance Treatment For Patients With Chronic Obstructive Pulmonary Disease With An Eosinophilic Phenotype

On Wednesday, US drug company Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) sold its entire stake in Haleon Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>) to institutional investors and the consumer healthcare firm at 385 pence per share ($5.00).
Under the deal, Haleon agreed to purchase approximately 44 million ordinary shares at 385 pence from Pfizer off-market for an aggregate consideration of approximately 170 million pounds, or $220 million.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44311862/pfizers-direct-to-consumer-model-faces-scrutiny-from-us-senators" rel="noreferrer noopener">Pfizer&#8217;s Direct-To-Consumer Model Faces Scrutiny From US Senators&nbsp;</a>
Pfizer has <a href="https://www.londonstockexchange.com/news-article/market-news/pricing-of-offering-in-haleon-plc-by-pfizer-inc/16947121" target="_blank" rel="noreferrer noopener">sold</a> approximately 618 million ordinary shares in Haleon to institutional investors at 385 pence per share, raising gross sale proceeds of approximately 2.4 billion pounds, or $3.1 billion.
After the off-market purchase and Pfizer&#8217;s offering to institutional investors, Pfizer&#8217;s interest in Haleon&#8217;s issued ordinary shares with voting rights is <a target="_blank" href="https://www.londonstockexchange.com/news-article/HLN/update-on-off-market-purchase-alongside-pfizer/16947343" rel="noreferrer noopener">expected</a> to reduce from approximately 7.3% to nil.
Brian McNamara, CEO of Haleon, commented:&nbsp;&#8220;Today&#8217;s transaction is an important milestone for the business and marks Pfizer fully exiting its stake in Haleon, having been at 32% at the time of demerger in July 2022. Our participation in the offering is consistent with our disciplined capital allocation priorities, and supports our commitment to deliver attractive returns for shareholders, underpinned by a strong investment grade balance sheet. Nearly three years on from demerger, Haleon is in a position of strength and is well placed to capitalize on the significant opportunities ahead.&#8221;
Settlement of the offering is expected to occur on March 21.
In October 2024, Pfizer divested a $3.3 billion stake in&nbsp;Haleon, reducing its holding from 22.6% to 15% in the British <a target="_blank" href="https://www.benzinga.com/markets/equities/24/10/41112790/pfizer-divests-3-3b-stake-in-sensodyne-toothpaste-and-panadol-painkiller-maker-haleon" rel="noreferrer noopener">consumer healthcare company</a>.
In May 2024, GSK plc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>)&nbsp;confirmed&nbsp;the sale of 385.3 million shares in&nbsp;Haleon&nbsp;for $1.58 billion, fully exiting its <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38895933/gsk-completely-exits-sensodyne-toothpaste-maker-haleon-in-1-6b-sale" rel="noreferrer noopener">position in Haleon</a>.&nbsp;
In the fourth-quarter earnings release, Haleon projects 2025 organic revenue to grow between 4% and 6%. Haleon expects organic revenue and operating profit growth to be weighted towards the s<a target="_blank" href="https://www.benzinga.com/general/health-care/25/02/44012867/sensodyne-toothpaste-maker-haleon-expects-profit-to-be-weighted-towards-second-half-of-2025" rel="noreferrer noopener">econd half of the year</a>.
Reuters notes that following Pfizer&#8217;s disposal, BlackRock Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BLK#NYSE">BLK</a>)&nbsp;unit will become Haleon&#8217;s largest shareholder with a more than 5% stake.
Price Action: HLN stock is down 0.05% at $10.28, and PFE stock is up 0.30% at $26.38 at the last check Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/25/03/44396572/nvidia-introduces-new-ai-and-robotics-tools-at-gtc-powering-the-future-of-technology" target="_blank" rel="noreferrer noopener">NVIDIA Introduces New AI And Robotics Tools At GTC, Powering The Future Of Technology</a></li>
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Photo: Shutterstock

Pfizer Offloads Its Last 7% Stake In Consumer Health Haleon For Over $3 Billion

Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) stock is trading lower during the premarket trading session on Wednesday.
According to a Tuesday report in the Wall Street Journal, the Health and Human Services Department (HHS) is considering substantial reductions in federal funding for <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">domestic HIV prevention</a>.
According to people familiar with the matter, the WSJ reports that the plans could be announced within a day. However, they are not final and could still be changed or canceled.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44283318/gilead-presents-new-hiv-treatment-and-cure-research-data" rel="noreferrer noopener">Gilead Presents New HIV Treatment And Cure Research Data</a>
The Centers for Disease Control and Prevention (CDC) has a department focused on preventing HIV and other infectious diseases. It provides funding for state and local programs, including HIV tracking, syringe services, and community outreach, the WSJ writes.
Meanwhile, the Trump administration is planning significant staff cuts at the CDC as part of a broader reorganization, according to WSJ sources. The agency's structure makes it vulnerable to such changes since no single law defines its mission or programs.
Mitchell Warren, executive director of HIV prevention group AVAC, says the CDC's pre-exposure prophylaxis (PrEP) program could be reduced or cut. Launched last fall as a pilot program, it provides free medication to help prevent HIV.
PrEP&nbsp;is used by people who are HIV-negative and at high risk of being exposed to HIV infection.
In 2021, the FDA approved ViiV Healthcare's Apretude, the first injectable form of PrEP <a target="_blank" href="https://www.benzinga.com/24/12/42468692/gilead-unveils-new-yearly-hiv-injection-to-offer-hope-for-less-frequent-preventive-dosing" rel="noreferrer noopener">administered every two months</a>. ViiV Healthcare is owned by Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), and Shinogi Ltd.
In 2023, the agency <a target="_blank" href="https://www.cdc.gov/nchhstp/budget-funding/index.html#cdc_program_funding_fund_by_cat-how-is-cdc-funding-used-for-hiv-viral-hepatitis-stis-tuberculosis-prevention" rel="noreferrer noopener">allocated</a> approximately $1.3 billion to combat HIV, viral hepatitis, sexually transmitted infections, and tuberculosis. Roughly 75% of those funds support state and local health departments, nonprofits, and other organizations engaged in disease prevention and outbreak response.
"No final decision on streamlining CDC's HIV Prevention Division has been made," the WSJ report <a target="_blank" href="https://www.wsj.com/health/healthcare/trump-administration-weighing-major-cuts-to-funding-for-domestic-hiv-prevention-8dcad39b" rel="noreferrer noopener">added</a>, citing the department's spokesman.
Gilead filed for regulatory approval of lenacapavir for PrEP (twice a year) last year and expects a potential <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43673047/gilead-ups-2025-outlook-eyes-lenacapavir-launch-for-hiv-prevention" rel="noreferrer noopener">commercial launch in 2025</a>.&nbsp;
Gilead also&nbsp;revealed that it is developing a once-yearly injectable formulation for lenacapavir. In its investor presentation, the company expects&nbsp;the pivotal Phase 3 pharmacokinetics study's first patient to be in 2025, and potential regulatory filings will <a target="_blank" href="https://www.benzinga.com/24/12/42468692/gilead-unveils-new-yearly-hiv-injection-to-offer-hope-for-less-frequent-preventive-dosing" rel="noreferrer noopener">begin in late 2027</a>.
Price Action: At the last check on Wednesday, GILD stock was down 2.02% at $108 during the premarket session.
Read Next:
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<li><a href="https://www.benzinga.com/25/03/44393734/siemens-to-slash-6000-jobs-as-demand-slows-in-germany-and-china" target="_blank" rel="noreferrer noopener">Siemens To Slash 6,000 Jobs As Demand Slows In Germany And China</a></li>
</ul>

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Trump Administration Weighs Deep Cuts To Domestic HIV Prevention Programs, Gilead Stock Slides

<a href="https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024" title="https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024">https://www.bloomberg.com/news/articles/2025-03-14/us-measles-cases-so-far-this-year-surpass-total-for-all-2024</a>

'U.S. Measles Cases In 2025 Have Already Surpassed The Total For The Entire Year Of 2024' - Bloomberg

ViiV Healthcare announced Wednesday the latest findings from its <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">EMBRACE phase 2b study</a>.
The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), kept viral levels suppressed in adults living with HIV who were already <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/b44280792/viiv-healthcares-investigational-broadly-neutralising-antibody-n6ls-successfully-maintains-viral-s" rel="noreferrer noopener">stable on treatment</a>.
These results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025).
Results from the EMBRACE study at the six-month primary endpoint showed:
<ul>
<li>96% of participants receiving VH109 60mg/kg intravenously (IV) and 88% receiving VH109 3000mg subcutaneously (SC) with rHuPH20 maintained HIV-1 RNA levels below 50 copies/mL, compared to 96% in the standard-of-care group.</li>
</ul>
<ul>
<li>Overall, 4% of the IV group and 6% of the SC group had HIV-1 RNA levels of 50 copies/mL or higher when measured at month six, compared to none in the standard-of-care group.</li>
</ul>
<ul>
<li>VH109 was generally well tolerated, though infusion site reactions were more frequent with SC administration, occurring in 14% compared to none with IV administration.</li>
</ul>
<ul>
<li>ViiV Healthcare will progress a six-month IV formulation of VH109 in combination with CAB LA for further evaluation in an EMBRACE part two trial.</li>
</ul>
The company also presented data from two phase 2a proof-of-concept studies of investigational antiretroviral therapies, VH4524184 <a href="https://www.benzinga.com/pressreleases/25/03/b44261960/viiv-healthcare-showcases-leadership-in-long-acting-injectables-innovation-at-croi-2025-with-data-" target="_blank" rel="noreferrer noopener">(VH184) and VH4011499 (VH499)</a>.
Also Read: 
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<li><a href="https://www.benzinga.com/general/biotech/24/07/39915897/pfizer-and-gsks-viiv-healthcares-two-drug-hiv-treatment-matches-gileads-three-drug-combo-in-major" target="_blank" rel="noreferrer noopener">Pfizer And GSK&#8217;s ViiV Healthcare&#8217;s Two-Drug HIV Treatment Matches Gilead&#8217;s Three-Drug Combo In Major Trial</a></li>
</ul>
VH184 demonstrated potency at all doses. After 10 days of monotherapy, the average decreases were -1.17, -2.15, and -2.31 log10 copies/mL for the 10mg, 50mg, and 300mg doses, respectively.
<ul>
<li>The maximum viral load decline (-2.69 log10) was observed in the 300mg dose. Additionally, no drug-resistance mutations were observed at the end of the study.</li>
<li>Long-acting formulations of VH184 in adults without HIV are being evaluated in an ongoing phase 1 study.</li>
</ul>
<ul>
<li>The trial of VH499 showed that all oral doses (25mg, 100mg, and 250mg) led to a decrease in HIV-1 viral load ranging from -2.2 log10 copies/mL in the 250mg arm to -1.8 log10 copies/mL in the 25mg and 100mg arms. VH499 was well tolerated, with all adverse events being mild to moderate in severity.</li>
<li>There were no adverse events leading to withdrawal, and no serious adverse events were reported</li>
<li>On day 11, one individual on the 25mg dose developed a single mutation associated with reduced susceptibility to capsid inhibitors.</li>
</ul>
ViiV Healthcare is majority owned by GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), with Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Shionogi as shareholders.
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</ul>

GSK, Pfizer's ViiV Healthcare Shows Strong HIV Viral Suppression In Latest Study

<ul>
<li>Results from the phase IIb study, EMBRACE, demonstrate that N6LS, a bNAb administered every four months, effectively maintained undetectable viral load when combined with cabotegravir long-acting (CAB LA)</li>
<li>Results add to the growing body of evidence that N6LS is a potent antiviral that can function as a component of a complete antiretroviral regimen</li>
<li>EMBRACE study to continue investigating a combination of N6LS dosed at six months with CAB LA</li>
</ul>
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced positive findings from the company's EMBRACE phase IIb study.1 The study found that N6LS (VH3810109 or VH109), given every four months in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV who were already stable on treatment. It was also well tolerated by participants.
These results were presented today at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) in San Francisco, U.S.

ViiV Healthcare Announces Findings From The Company's EMBRACE Phase IIb Study; N6LS Maintains Viral Suppression In Long-acting Treatment Of HIV

On Wednesday, Zymeworks Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZYME#NASDAQ">ZYME</a>) released fourth-quarter financial results. The company reported an earnings loss of 31 cents per share, missing the <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">consensus loss of 3 cents</a>.
Sales came at $31.03 million, missing the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $45.2 million</a>.
In its fourth-quarter earnings results, Zymeworks said it is increasing its development <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/g44151625/zymeworks-provides-corporate-update-and-reports-fourth-quarter-and-full-year-2024-financial-result" rel="noreferrer noopener">efforts on plans for ZW251</a>.
&#8220;Based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients, we have decided to reprioritize resources for the advancement of ZW251, for which an IND submission is now planned for mid-2025,&#8221; Zymeworks said in a statement.
&#8220;As a result, we have paused preparations for the commencement of Phase 1 studies of ZW220 at this time. However, we believe ZW220 remains a highly differentiated, IND-ready ADC with encouraging preclinical data and strong commercial rationale with partnership potential. We look forward to providing future updates on the development for ZW220,&#8221; the company added.
The company plans to initiate a Phase 1 trial for ZW251 this year.
&#8220;ZW251 provides a new therapeutic modality option targeting GPC3 for hepatocellular carcinoma and represents an emerging opportunity in oncology that has yet to be fully realized,&#8221; said Zymeworks Chief Scientific Officer Paul Moore. &#8220;With a potential best-in-class design and differentiated mechanism, we believe our pipeline presents meaningful opportunities for both strategic partnerships and value creation&#8230;&#8221;
In February, Zymeworks achieved a <a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/g43967501/zymeworks-announces-achievement-of-14-million-milestone-from-gsk-collaboration" rel="noreferrer noopener">$14 million cash research</a> milestone associated with a clinical milestone from GSK Plc.
In November 2024, the FDA granted accelerated approval to Zymeworks and Jazz Pharmaceuticals Plc partnered Ziihera (zanidatamab) for adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42106981/fda-grants-u-s-approval-of-ziihera-zanidatamab-hrii-for-the-treatment-of-adults-with-previously-tr" rel="noreferrer noopener">biliary tract cancer</a>.
Ziihera was approved under accelerated approval based on a 52% objective response rate (ORR) and a median duration of response of 14.9 months. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Price Action: ZYME stock is down 7.97% at $12.13 at the last check Thursday.
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Photo via Shutterstock.

Earnings

JAZZ

ZYME

Cancer-Focused Zymeworks' Q4 Earnings Miss Expectations, Reprioritize Resources To Focus On ZW251

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that Quebec has become the first province to publicly reimburse APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals who are HIV-1 negative.1
ViiV Healthcare commends the Quebec government for its decision to grant timely access to APRETUDE for at-risk individuals who could benefit from PrEP. APRETUDE is now listed under the Régie de L'assurance Maladie du Québec (RAMQ). With cases of HIV continuing to rise across Canada, including in Quebec where cases have increased 37 per cent between 2019 and 2022,2 this decision will have a meaningful impact on HIV prevention efforts in the province.
APRETUDE is the first and only long-acting injectable approved in Canada to help reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents aged 12 years and older, and weighing at least 35kg.1 Findings from two real-world evidence studies (OPERA and Trio Health cohorts) showed more than 99 per cent effectiveness of APRETUDE for PrEP in nearly 1,300 individuals.3,4&nbsp;APRETUDE for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in reducing the risk of HIV acquisition in two clinical trials, providing more options for PrEP for Canadians.1

Global

ViiV Healthcare Announces That Quebec Has Become The First Province To Publicly Reimburse  APRETUDE For Pre-Exposure Prophylaxis To Reduce The Risk Of Sexually Acquired HIV-1 Infection In At-Risk Individuals Who Are HIV-1 Negative

The Institute for Clinical and Economic Review (ICER) released a report on Monday assessing the clinical effectiveness and value of GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) chronic obstructive pulmonary disease (COPD) treatments, Trelegy Ellipta and Breo Ellipta.
Under the Inflation Reduction Act, CMS is negotiating prices for select Medicare Part D drugs. In the current cycle, Trelegy Ellipta and Breo Ellipta are among the medications under review, alongside 15 other drugs slated for <a target="_blank" href="https://www.benzinga.com/25/01/43062779/popular-ozempic-wegovy-selected-for-next-round-of-medicare-drug-price-negotiations" rel="noreferrer noopener">pricing changes in 2027</a>.
The findings will be submitted to the Centers for Medicare &amp; Medicaid Services (CMS) as part of ongoing Medicare drug price negotiations.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/03/44084214/gsk-twice-yearly-depemokimab-reduces-nasal-polyp-size-improves-symptoms-in-chronic-rhinosinusitis-goes-under-fda-review-for-two-indications" rel="noreferrer noopener">GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review</a>
ICER President and CEO Sarah K. Emond emphasized the significance of the report, highlighting that over 15 million Americans suffer from COPD.
Both inhalers provide the advantage of once-daily dosing, a key difference from their comparators, which typically require multiple inhalers used twice daily.
Observational <a target="_blank" href="https://icer.org/news-insights/press-releases/icer-publishes-special-report-on-copd-therapies-as-part-of-cms-public-comment-process-on-medicare-drug-price-negotiations/" rel="noreferrer noopener">data</a> suggest that patients are more likely to adhere to once-daily therapies, potentially reducing COPD exacerbations, although the certainty of this outcome remains moderate.
Patient feedback also indicated a preference for single-inhaler, once-daily treatments. No major differences in adverse effects were observed between these inhalers and their alternatives.
Trelegy Ellipta, a triple-therapy inhaler containing an inhaled corticosteroid (ICS), a long-acting muscarinic antagonist (LAMA), and a long-acting beta-agonist (LABA), was found to offer comparable or incremental net health benefits compared to generic triple therapies that require multiple inhalers.
Breo Ellipta, a dual-therapy inhaler combining an ICS and LABA, was similarly found to provide comparable or incremental net health benefits when compared to generic ICS/LABA inhalers.
ICER's report also analyzed cost-effectiveness, framing pricing calculations based on comparator therapies, including low-cost, authorized, and discounted brand-name drugs.
The report provides estimated price thresholds that CMS should consider in negotiations, though the actual prices paid by CMS for comparator drugs remain undisclosed.
Price Action: GSK stock is up 2.55% at $38.92 at the last check Tuesday.
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</ul>
Photo by HJBC via Shutterstock

GSK's Once-Daily Inhalers For Smoker's Lung Has Potential Benefits: Independent Organization Report

On Monday, the Food and Drug Administration (FDA) accepted for review GSK plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) marketing application for <a href="https://www.benzinga.com/general/biotech/25/01/43010436/gsk-highlights-new-approvals-vaccine-momentum-at-jp-morgan-healthcare-conference" target="_blank" rel="noreferrer noopener">depemokimab in two indications</a>.
The company released topline data from the trials in October 2024.
The <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/" rel="noreferrer noopener">proposed</a> indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Also Read:<a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38939147/gsks-experimental-asthma-drug-reduces-severe-attacks-phase-3-trial-data-shows" rel="noreferrer noopener"> GSK&#8217;s Experimental Asthma Drug Reduces Severe Attacks, Phase 3 Trial Data Shows</a>
The Prescription Drug User Fee Act (PDUFA) date is Dec. 16, 2025.
On Saturday, GSK announced full results from the ANCHOR-1 and ANCHOR-2 phase 3 trials of depemokimab versus placebo (both with the standard of care [SOC]) in adults with CRSwNP.
ANCHOR-1 (N=271) and ANCHOR-2 (N=257) <a target="_blank" href="https://www.gsk.com/en-gb/media/press-releases/depemokimab-delivers-clinically-meaningful-and-statistically-significant-improvements-for-patients-with-chronic-rhinosinusitis-with-nasal-polyps-crswnp/" rel="noreferrer noopener">met</a> their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction versus placebo.
Additionally, a pooled analysis of the two trials showed improvements (reductions) from baseline versus placebo measured by:
<ul>
<li>Nasal polyp score (NPS, 0-8) at 52 weeks.</li>
<li>Mean nasal obstruction scores.</li>
</ul>
The treatment benefits were observed by the first assessment and sustained to week 52.
In pooled analyses of the secondary endpoints from both studies, nominally significant improvements favoring depemokimab versus placebo were observed.
When considering intervention with surgery or disease-modulating medication alone, the results still trended in depemokimab's favor. Up to 88% (n=239) of depemokimab-treated patients did not have surgery or disease-modulating medication vs. 83% (n=213) in the placebo group.
Price Action: GSK stock is up 2.04% at $38.36 at the last check Monday.
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Image: Shutterstock

GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review

On Saturday, Amgen&nbsp;Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) and AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) announced full results from the Phase 3, registrational WAYPOINT trial evaluating the efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44066175/positive-results-from-tezspire-tezepelumab-ekko-phase-3-waypoint-trial-highlight-rapid-sustained-e" rel="noreferrer noopener">with nasal polyps (CRSwNP)</a>.
The company released topline <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41843534/astrazeneca-amgens-asthma-drug-aces-late-stage-study-in-patients-with-chronic-rhinosinusitis" rel="noreferrer noopener">data in November 2024</a>.
The data demonstrated that Tezspire&nbsp;(tezepelumab-ekko) significantly reduced nasal polyp severity, the need for surgery, and systemic corticosteroid use in CRSwNP (nasal polyps) patients compared to placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41756467/upstream-bio-is-new-on-nasdaq-can-potentially-beat-astrazenecas-asthma-drug-on-effi" rel="noreferrer noopener">Upstream Bio Is New On NASDAQ, Can Potentially Beat AstraZeneca&#8217;s Asthma Drug On Efficacy, Analysts Say</a>
Treatment with Tezspire significantly reduced nasal polyp severity: the Nasal Polyp Score (NPS) was -2.065, and the nasal congestion score was -1.028 at week 52 compared to placebo.
Improvements in NPS were observed as early as week four and nasal congestion as early as week two (the first post-treatment assessments, respectively) and were sustained through week 52.1
Statistically significant and clinically meaningful improvements were observed across all key secondary outcomes assessed in the overall trial population.
Tezspire significantly reduced the need for nasal polyp surgery by 98% and systemic corticosteroid treatment by 88% compared to placebo.
In patients with CRSwNP, Tezspire had a safety profile consistent with its approved severe asthma indication.
Tezspire is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
Tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus.
In May, Amgen&nbsp;and&nbsp;AstraZeneca announced the results of the Phase 2a COURSE trial of Tezspire&nbsp;for severe chronic <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38924821/amgenastrazeneca-say-asthma-drug-shows-activity-in-another-lung-disease-across-broad-patient-popu" rel="noreferrer noopener">obstructive pulmonary disease</a>.
The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant.
The proof-of-concept study showed that, in patients with BEC ≥150 cells/µL, tezepelumab led to a nominally significant reduction of 37% in the rate of moderate or severe exacerbations compared to placebo.
Price Action: AMGN stock traded higher by 0.77% to $310.51 at the last check on Monday. AZN stock is up 0.10% to $76.29 at the last check Monday.
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Photo via Shutterstock

AMGN

Amgen-AstraZeneca Partnered Asthma Drug Shows Rapid And Sustained Effect In Chronic Rhinosinusitis

<ul>
<li>If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing</li>
<li>Submissions based on data from positive SWIFT and ANCHOR trials</li>
<li>SWIFT-1 and -2 showed depemokimab reduced exacerbation and hospitalisation rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo</li>
<li>ANCHOR-1 and -2 showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo</li>
</ul>

The FDA Has Accepted For Review GSK's Biologics License Application For The Use Of Depemokimab In Two Indications, The Prescription Drug User Fee Act Date Is 16 December 2025

<ul>
<li>ANCHOR-1 and ANCHOR-2 phase III trials show improvements in nasal polyp size and obstruction for depemokimab with twice-yearly dosing versus placebo.</li>
<li>Results with depemokimab were observed early at first assessment and sustained over 52 weeks.</li>
</ul>

On Saturday, GSK Announced Full Results From ANCHOR-1 and ANCHOR-2 Phase 3 Trials Assessing The Efficacy And Safety Of Depemokimab Versus Placebo In Adults With Chronic Rhinosinusitis With Nasal Polyps

London-based consumer healthcare group Haleon Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HLN#NYSE">HLN</a>) stock is trading lower on Thursday.
Haleon, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) spun off, reported revenue of 11.23 billion pounds (US$14.19 billion) for 2024. That&#8217;s down marginally by 0.6%.
Organic revenue growth was 5.0% with +3.7% price and +1.3% volume/mix with +6.8% organic growth in the fourth quarter.
Adjusted operating profit for 2024 <a href="https://www.haleon.com/news/press-releases/corporate/2025/2024-full-year-results" target="_blank" rel="noreferrer noopener">stood</a> at 2.5 billion pounds, down 6.5% at constant currency.
<ul>
<li>Oral Health: Revenue increased by 5.6% to 3.3 billion, with organic revenue growth of 9.6%.</li>
<li>Vitamins, Minerals, and Supplements: 2024 revenues increased by 3.4% to 1.7 billion with organic growth of 7.6%, including 8.2% organic growth in Q4 2024.</li>
<li>Pain Relief: Revenue declined 3.3%, with broadly flat organic growth of 0.1%, resulting in 2.6 billion in revenue.</li>
<li>Respiratory Health: Revenue declined 3.4% to 1.7 billion, with organic revenue growth of 0.9% and (1.3)% in the fourth quarter.</li>
</ul>
2024 growth was muted compared to recent years. This reflects a combination of lapping strong cold and flu comparatives arising from significantly elevated Contac demand in China in Q1 2023 from the lifting of COVID-19-related restrictions and a softer cold and flu season in H2 2024, particularly in the US.
Digestive Health and Other revenue declined 7.2% to 2 billion.
Guidance: The company projects 2025 organic revenue to grow between 4% and 6%. Haleon expects organic revenue and operating profit growth to be weighted towards the second half of the year.
The company expects a foreign exchange translation headwind of approximately 1.0% and 2.5% to negatively impact net revenue and adjusted operating profit.
&#8220;We are well positioned to drive organic revenue growth within our medium-term guidance range, with strong organic profit growth in 2025,&#8221; CEO Brian McNamara said in a statement.
Over the medium term, Haleon expects annual organic revenue growth of 4-6%.
Price Action: HLN stock is down 4.12% at $9.78 during the premarket session at the last check Thursday.
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Image: Shutterstock

Sensodyne Toothpaste Maker Haleon Expects Profit To Be Weighted Towards Second Half Of 2025

Press Releases

Deadline Alert: GSK plc. (GSK) Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit

GSK Deadline: GSK Investors Have Opportunity to Lead GSK plc Securities Fraud Lawsuit

GSK IMPORTANT DEADLINE: ROSEN, NATIONAL INVESTOR COUNSEL, Encourages GSK plc Investors to Secure Counsel Before Important April 7 Deadline in Securities Class Action – GSK

Class Action Filed Against GSK plc (GSK) Seeking Recovery for Investors - Contact The Gross Law Firm

INVESTOR ALERT: Pomerantz Law Firm Reminds Investors with Losses on their Investment in GSK plc of Class Action Lawsuit and Upcoming Deadlines - GSK

DEADLINE ALERT for MPWR, GSK, and ICLR: The Law Offices of Frank R. Cruz Reminds Investors of Class Actions on Behalf of Shareholders

Shareholders of GSK plc Should Contact The Gross Law Firm Before April 7, 2025 to Discuss Your Rights – GSK

Shareholders of GSK plc Should Contact Levi & Korsinsky Before April 7, 2025 to Discuss Your Rights - GSK

GSK plc Securities Fraud Class Action Lawsuit Pending: Contact Levi & Korsinsky Before April 7, 2025 to Discuss Your Rights – GSK

GSK plc. (GSK) Investors Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit

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